Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706) (RUBY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00482612
First received: June 1, 2007
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.


Condition Intervention Phase
Insomnia
Drug: Esmirtazapine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Two-Week, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Efficacy and Safety Out-Patient Trial With Org 50081 in Patients With Chronic Primary Insomnia

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period [ Time Frame: Day 1 to Day 15 ] [ Designated as safety issue: No ]
    TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 14-day active treatment period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present was used in the analysis.


Secondary Outcome Measures:
  • Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period [ Time Frame: Day 1 to Day 15 ] [ Designated as safety issue: No ]
    SL was defined as the duration of time measured in minutes that it took a participant to fall asleep as recorded daily in the participant's sleep diary. SL values over the 14-day active treatment period were averaged for each participant, and average SL was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present were used in the analysis.

  • Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period [ Time Frame: Day 1 to Day 15 ] [ Designated as safety issue: Yes ]
    The total number of participants with an AE during the 14-day In-treatment Period was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  • Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period [ Time Frame: Day 1 to Day 15 ] [ Designated as safety issue: Yes ]
    The total number of participants discontinuing from study treatment due to experiencing an AE was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.


Enrollment: 526
Study Start Date: December 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Esmirtazapine 1.5 mg
Esmirtazapine 1.5 mg tablet, oral administration in the evening, once daily, for 2 weeks
Drug: Esmirtazapine
Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia [USP] name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.
Other Names:
  • Org 50081
  • MK-8265
Experimental: Esmirtazapine 3.0 mg
Esmirtazapine 3.0 mg tablet, oral administration in the evening, once daily, for 2 weeks
Drug: Esmirtazapine
Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia [USP] name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.
Other Names:
  • Org 50081
  • MK-8265
Experimental: Esmirtazapine 4.5 mg
Esmirtazapine 4.5 mg tablet, oral administration in the evening, once daily, for 2 weeks
Drug: Esmirtazapine
Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia [USP] name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.
Other Names:
  • Org 50081
  • MK-8265
Placebo Comparator: Placebo
Placebo to esmirtazapine
Drug: Placebo
Placebo tablets containing the following excipients: hydroxypropyl cellulose, maize starch (USP name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has signed written informed consent after the scope and nature of the investigation was explained to them
  • Has difficulty falling asleep, maintaining sleep or has early morning awakenings

Exclusion Criteria:

  • Significant medical or psychiatric illness causing sleep disturbances
  • Has a history of bipolar disorder or family (immediate family) of suicide
  • Has sleep disorder such as sleep related breathing disorder, restless leg syndrome, narcolepsy
  • Has significant other medical illness such as acute or chronic pain, heart, kidney or liver disease within the last year
  • Currently diagnosed or meets the criteria for Major Depressive Disorder (MDD) or has been treated for MDD with the last 2 years
  • Substance abuse, excessive use of alcohol (as determined by the physician) or drug addiction within the last year.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482612

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00482612     History of Changes
Other Study ID Numbers: P05706, 176001, MK-8265-003
Study First Received: June 1, 2007
Results First Received: June 9, 2014
Last Updated: July 18, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014